Cleared Abbreviated

K041919 - PERFUDROP AIR M-P WITH NEEDLE 20 G, MODEL 48451606

K041919 is an FDA 510(k) clearance for PERFUDROP AIR M-P WITH NEEDLE 20 G, manufactured by Clinico. The device is a Class 2 General Hospital device with product code FPA cleared through the Abbreviated 510(k) pathway after a 80-day FDA review.

K041919 · Clinico · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
80d
Days
Class 2
Risk

K041919 is an FDA 510(k) clearance for the PERFUDROP AIR M-P WITH NEEDLE 20 G, MODEL 48451606. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Clinico (Bad Hersfeld, DE). The FDA issued a Cleared decision on October 4, 2004 after a review of 80 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Clinico devices

FDA 510(k) Submission Details - K041919

510(k) Number K041919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2004
Decision Date October 04, 2004
Days to Decision 80 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 129d · This submission: 80d
Pathway characteristics
Standards-based clearance path.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FPA Set, Administration, Intravascular

All 728
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